Human plasma enriched in immunoglobulins is used for the treatment of many disorders as well as to treat certain congenital deficiencies. Typically, human plasma is obtained by pooling the plasma from multiple donors, having different blood group types. Blood group types may be divided into 4 major types. Blood group type A—having only the A antigen on red cells (and B antibody in the plasma); blood group type B—having only the B antigen on red cells (and A antibody in the plasma); blood group type AB—having both A and B antigens on red cells (but neither A nor B antibody in the plasma); and blood group type O—having neither A nor B antigens on red cells (but both A and B antibody are in the plasma).
It is important that the red bloods cells of a person having a particular blood group type antigen, such as A, never come in contact with the antibodies that will bind to this antigen, such as anti-A antigen antibodies, because contact with such antibodies would result in agglutination and/or hemolysis of their red blood cells that can even result in death. Therefore, a recipient having blood group type A may only receive plasma from a donor having blood group type A or blood group type AB; a recipient having blood group type B may only receive plasma from a donor having blood group type B or blood group type AB; a recipient having blood group AB may only receive plasma from a donor having blood group type AB; and a recipient having blood group type O is deemed a universal recipient. Compatibility of the different blood group types is important for the development of safe blood transfusions and organ transplants. However, in case of blood derived therapeutic drugs that rely on pooling of blood plasma from a large numbers of people to obtain a consistent average of protein components, it becomes particularly challenging to ensure that a recipient does not receive non-compatible plasma.
A number of approaches have been developed to selectively remove blood group type antibodies from plasma, including formalinized heat-treated red cells (Vox Sang., 1967, 12, 75-77), heat treated Escherichia coli O86:B7 having A and B antigens (Transfusion, 1972, 12, 98-102), red cell stroma powder, red cell stroma antigen derived immunoadsorbents (Chemical Soc. Rev., 1978, 7, 423-452), and synthetic blood group A and B immunoadsorbents (Rev. Fr. Transfus. Immunohematol. 1981, 24, 3, 281-287).
Solid phase chromatography immunoadsorbents have been developed as commercial chromatography media for the treatment of blood derived products and also for the preparation of donors before transplantation to an ABO incompatible recipient. One of the key advantages of employing synthetic immunoadsorbents is that they are synthetically constructed instead of being derived from natural sources and therefore have more consistent properties from batch to batch.
Currently, some of the commercially available chromatographic media with blood group A antigen (A-antigen) ligands and/or blood group B antigen (B-antigen) ligands include the Glycosorb-ABO device (Glycorex Transplantation AB). This Glycosorb device is used to prepare organ donors for transplantation to patients having incompatible blood types. The blood group antigen ligands in the Glycosorb-ABO device bind and remove the blood group A antigen antibodies (anti-A) and blood group B antigen antibodies (anti-B) from the blood of organ donors thus reducing the risk of organ rejection.
One of the major challenges in utilizing chromatography media for the purification of blood derived products is the lack of an efficient and reproducible method to evaluate the relative quality of different media, e.g., different batches of same type of media or media from different sources or the same media samples over time.